The Effect of Bariatric/Metabolic Surgery on GFR

Metabolic Syndrome Clinical Trial

Official title:

Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02406664
• Other study ID #: NCT02271568
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2015
• Last updated: February 18, 2016
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Hanyang University
• Contact: Tae Kyung Ha, MD,PhD
• Phone: 82-2-2290-8444
• Email: missurgeon[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.

Description:

Metabolic syndrome is strongly associated with obesity and the patients with this syndrome are at increased risk for cardiovascular disease. Obesity constitutes a strong risk factor for the development of chronic kidney disease. Among diabetics, obesity is known to amplify the risk for kidney disease. Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome. In addition, many observational studies have demonstrated significant reduction in proteinuria after bariatric surgery.

However, the changes in the component of cardiovascular problem among metabolic syndrome and changes in renal filtration function or progression to end stage kidney disease in morbidly obese patients after weight loss surgery have not been extensively studied. Therefore, our study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Morbid obesity (BMI>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension)

• Morbid obese patients (BMI>35)

Exclusion Criteria:

• Prior bariatric surgery

• Malignancy (any type)

• End stage renal disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Procedure:
• Bariatric surgery
Laparoscopic or Robot R-Y gastric bypass

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glomerular filtration rate		before, 6, 12month after surgery	No
Secondary	Change in excessive body weight		before, 6, 12month after surgery	No
Secondary	Systolic function (EF)	measured by echocardogram	Before, 6 and 12month after surgery	No
Secondary	Diastolic function (E,A,DT,IVRT,E/e')	measured by echocardogram	Before, 6 and 12month after surgery	No
Secondary	Change of daytime blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)	measured by 24 hours ambulatory blood pressure monitoring	Before, 6, and 12month after surgery	No
Secondary	Change of night time blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)	measured by 24 hours ambulatory blood pressure monitoring	Before, 6, and 12month after surgery	No
Secondary	Change of 24 hours blood pressure (systolic blood pressure, diastolic blood pressure, mean blood pressure)	measured by 24 hours ambulatory blood pressure monitoring	Before, 6, and 12month after surgery	No